FDA Guidance Maps Out Trial Design for COVID-19 Drugs

May 18, 2020

Sponsors of drugs to treat or prevent COVID-19 should focus on populations that are the hardest-hit and least-represented in clinical trials, including minorities and the elderly, according to a new FDA guidance released last week.

The guidance encourages sponsors to locate trials in areas with higher concentrations of racial and ethnic minorities and even to consider conducting trials on geriatric patients located in nursing homes or elder care facilities.

The FDA “strongly recommends” trial designs that compare the investigational drug to placebo and standard of care, and notes that trial revisions may be necessary to keep up with important new discoveries that may alter the accepted standard of care.

The guidance also encourages trial designs that use an independent data monitoring committee to ensure subject safety and data integrity.

Sponsors also should be prepared to open new sites or close existing sites based on regional spread of the virus. And they should develop criteria in advance for stopping a trial in the case of drug futility or the risk of patient harm.

In a separate guidance issued last week, the FDA recommends sponsors begin COVID-19 drug development activities by requesting a pre-IND meeting with the agency. To move quickly, the FDA is consolidating the standard pre-IND meeting request and package development processes into a single step and establishing a multispecialty, multidisciplinary team to focus on proposal review.

Sponsors who already have an active IND or who have submitted a pre-IND request to expand an approved drug for a COVID-19 indication should submit a new meeting request for the COVID-19 indication.

The guidance outlines what information should be included in a pre-IND request for a COVID-19 trial and offers instructions for submitting requests to the agency.